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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6194-014 | Other Identifier | MSD |
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The goal of this study is to learn how safe MK-6194 is in healthy Chinese adults and how well people tolerate it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A | Experimental | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo. |
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| Panel B | Experimental | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo. |
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| Panel C | Experimental | Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6194 | Biological | Subcutaneous Administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to 42 days post dose |
| Number of Participants Who Discontinue Study Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to 42 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of MK-6194 | Blood samples will be collected at specified intervals to determine the AUC0-last of MK-6194. | Up to 42 days post dose |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194 |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital (Site 0001) | Beijing | Beijing Municipality | 100191 | China |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Placebo | Biological | Subcutaneous administration |
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Blood samples will be collected at specified intervals to determine the AUC0-inf of MK-6194. |
| Up to 42 days post dose |
| Maximum Serum Concentration (Cmax) of MK-6194 | Blood samples will be collected at specified intervals to determine the Cmax of MK-6194. | Up to 42 days post dose |
| Time to Maximum Serum Concentration (Tmax) of MK-6194 | Blood samples will be collected at specified intervals to determine the Tmax of MK-6194. | Up to 42 days post dose |
| Apparent Terminal Half-life (t1/2) of MK-6194 | Blood samples will be collected at specified intervals to determine the t1/2 of MK-6194. | Up to 42 days post dose |
| Apparent Clearance (CL/F) of MK-6194 | Blood samples will be collected at specified intervals to determine the CL/F of MK-6194. | Up to 42 days post dose |
| Apparent Volume of Distribution during terminal phase (Vz/F) of MK-6194 | Blood samples will be collected at specified intervals to determine the Vz/F of MK-6194. | Up to 42 days post dose |
| Incidence of Antidrug Antibodies (ADA) to MK-6194 | Blood samples will be collected at specified intervals to determine the ADA response to MK-6194. | Up to 42 days post dose |